A Polypill for Acute Coronary Syndrome
ConditionAcute Coronary Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.
Eligibility criteria
Qualifiers
Age ≥ 18
Hospitalization for acute coronary syndrome with percutaneous coronary intervention
Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin
Disqualifiers
Current need for systemic anticoagulation
Contraindication to receive any components of the polypill
History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
Comorbidities that might be expected to limit lifespan within the 12-month study period
Trial design
Treatments tested in this trial
- Polypill
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov